Carcinoma, Non-small Cell Lung
Conditions
Keywords
aprepitant, non-small cell lung cancer
Brief summary
Aprepitant is an oral neurokinin-1(NK-1) antagonist which is widely used for the prevention of chemotherapy-induced nausea and vomiting(CINV), it is metabolized by CYP34A, however, up to now it was still unknown the CINV control rate of aprepitant in Chinese non-small cell lung cancer(NSCLC) patients, we hypothesis that CYP3A4 and NK-1 polymorphism would influence aprepitant plasma concentration, which may lead to the individual difference of CINV control rate.
Detailed description
Patients pathologic diagnosed of advanced non-small cell lung cancer, according to NCCN non-small cell lung cancer guide line(2014 V2),the patient should receive standard platinum based chemotherapy, are randomized divided into two groups, aprepitant group and placebo group. In aprepitant group, patients would receive aprepitant 125 mg at day1, then 80 mg at day2 and day3. In placebo group, patients would receive placebo from day1 to day3. In both group, dexamethasone and 5-HT inhibitor palonosetron were give at the same dose. During the treatment, any grade of nausea and vomiting should be recorded in order to evaluate the complete response rate of CINV, other side-effects should be recorded. In aprepitant group, plasma should be taken for the analyze of plasma concentration, gene polymorphism of CYP3A4 and NK-1 should be analyzed for all the patients who received aprepitant if possible.
Interventions
DRUGAprepitant
aprepitant should be give when patients receive platinum based chemotherapy, 125mg for day1, 80mg for day2 and day3.
DRUGplacebo
placebo should be give when patients receive platinum based chemotherapy, 125mg for day1, 80mg for day2 and day3.
Sponsors
Hunan Province Tumor Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* patients pathologic diagnosed of advanced non-small cell lung cancer * according to NCCN non-small cell lung cancer guide line(2014 V2), patients are suitable for platinum based chemotherapy.
Exclusion criteria
* patients could not receive platinum based chemotherapy judged by clinical doctors * pregnancy or breast-feeding women * any serious disease which could not be controled * urine protein≥++, or 24h urine protein\>1g * less than 18 years old or more than 75 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complete response rate of CINV | during treatment, up to 6 months | complete response rate of CINV should be recorded when platinum based chemotherapy begun, during inhospital treatment, up to 6 months |
Secondary
| Measure | Time frame |
|---|---|
| adverse event | during treatment, up to 6 months |
Countries
China
Outcome results
None listed